Clinical trial · Interventional
CD19-targeted CAR T Cells for Relapsed and Refractory (R/R) Non-Hodgkins Lymphoma
A Phase II Open-Label, Single-Arm, Multicenter Study of JWCAR029, CD19-targeted Chimeric Antigen Receptor (CAR) T Cells for Relapsed and Refractory (R/R) Non-Hodgkins Lymphoma
NCT04089215CI-TRIAL-00071667unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a phase II, open-label, single-arm, multicenter study to asess the efficacy and safety of JWCAR029 in adult R/R Non-Hodgkins Lymphoma subjects in China.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
| Follicular Lymphoma | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Lymphoma, Non-Hodgkin | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CD19-targeted Chimeric Antigen Receptor (CAR) T Cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- JWCAR029 treatment
- description
- JWCAR029 be administrated in two dose level
- interventionNames
- Biological: CD19-targeted Chimeric Antigen Receptor (CAR) T Cells
Primary outcomes (2)
- measure
- Objective response rate (ORR) in LBCL subjects in cohort A;
- timeFrame
- 3 months
- description
- Objective response rate (ORR) in 3 month in cohort A of large B cell lymphoma (LBCL) subjects;
- measure
- Complete response rate (CRR) in FL subjects in cohort B
- timeFrame
- 3 months
- description
- Complete response rate (CRR) in 3 month in cohort B of follicular lymphoma (FL) subjects
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects must meet all of the following criteria to participate in the study: 1. ≥ 18 years old; 2. Sign on the informed consent; 3. Subject must have histologically confirmed large B lymphoma or follicular lymphoma; 4. Subjects have accessible PET-positive lesion and have measurable CT-positive lesion according to Lugano Classification; 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 6. Adequate organ function; 7. Adequate vascular access for leukapheresis procedure; 8. Subjects who have previously received CD19 targeted therapy must confirm that lymphoma lesions still express CD19; 9. Women of childbearing potential must agree to use highly effective methods of contraception for 1 year after the last dose of JWCAR029; 10. Males who have partners of childbearing potential must agree to use an effective barrier contraceptive method for 1 year after the last dose of JWCAR029. Exclusion Criteria: 1. Central nervous system (CNS) only involvement by malignancy or primary CNS lymphoma; 2. History of another primary malignancy that has not been in remission for at least 2 years; 3. Subjects has HBV, HCV, HIV or syphilis infection at the time of screening; 4. Deep venous thrombosis (DVT)/Pulmonary embolism (PE), or DVT/PE requires anti-coagulation within 3 months prior to signing the ICF; 5. Subjects with uncontrolled systemic fungal, bacterial, viral or other infection; 6. Presence of acute or chronic graft-versus-host disease (GVHD); 7. History of any serious cardiovascular disease or presence of clinically relevant CNS pathology; 8. Pregnant or nursing women; 9. Subjects using of any chemotherapy, corticisteriod, experiment agents, GVHD therapies, radiation, allo-HSCT or any other therapies for lymphoma must go through a specific wash-out period before leukapheresis; 10. Uncontrolled conditions or unwillingness or inability to follow the procedures required in the protocol; 11. Received CAR T-cell or other genetically-modified T-cell therapy previously.
References
Publications (4)
- RESULTYing Z, Yang H, Guo Y, Li W, Zou D, Zhou D, Wang Z, Zhang M, Wu J, Liu H, Zhang P, Yang S, Zhou Z, Zheng H, Song Y, Zhu J. Relmacabtagene autoleucel (relma-cel) CD19 CAR-T therapy for adults with heavily pretreated relapsed/refractory large B-cell lymphoma in China. Cancer Med. 2021 Feb;10(3):999-1011. doi: 10.1002/cam4.3686. Epub 2020 Dec 31. PMID 33382529
- DERIVEDSong Y, Zou D, Yang H, Wu J, Guo Y, Li W, Liu H, Xia Z, Zhang Y, Zhou Z, Zhu J. Two-year follow-up of relmacabtagene autoleucel in relapsed or refractory follicular lymphoma in RELIANCE study. Br J Haematol. 2025 Oct;207(4):1476-1483. doi: 10.1111/bjh.20122. Epub 2025 Sep 1. PMID 40888120
- DERIVEDYing Z, Yang H, Guo Y, Li W, Zou D, Zhou D, Wang Z, Zhang M, Wu J, Liu H, Wang C, Ma L, Yang S, Zhou Z, Qin Y, Song Y, Zhu J. Long-term outcomes of relmacabtagene autoleucel in Chinese patients with relapsed/refractory large B-cell lymphoma: Updated results of the RELIANCE study. Cytotherapy. 2023 May;25(5):521-529. doi: 10.1016/j.jcyt.2022.10.011. Epub 2023 Feb 24. PMID 36842849
- DERIVEDYing Z, Zou D, Yang H, Wu J, Guo Y, Li W, Liu H, Wang C, Ma L, Yang S, Zhou Z, Qin Y, Song Y, Zhu J. Preliminary efficacy and safety of Relmacabtagene autoleucel (Carteyva) in adults with relapsed/refractory follicular lymphoma in China: A phase I/II clinical trial. Am J Hematol. 2022 Dec;97(12):E436-E438. doi: 10.1002/ajh.26711. Epub 2022 Sep 14. No abstract available. PMID 36053875